Recruiting
Phase 1
Phase 2

Glutathione vs. Curcumin

Sponsor:

South Florida Veterans Affairs Foundation for Research and Education

Code:

NCT02848417

Conditions

Gulf War Syndrome

Eligibility Criteria

Sex: All

Age: 35 - 70

Healthy Volunteers: Accepted

Interventions

Curcumin

Glutathione

Placebo

Study Details

Brief summary:

The investigator proposes to perform a phase I/II study comparing two nutraceuticals and placebo that target mediators identified in the investigator's prior dynamic modeling study of Gulf War Illness (GWI). The investigator will repeat the dynamic modeling before treatment and on therapy to assess the modeling and the impact of the interventions on the homeostatic networks that have identified, with an added focus on the glutathione/redox system.

Conditions

Gulf War Syndrome

Study ID

NCT02848417

Start date

Apr, 2016

Status verified date

Jan, 2020

Completion date

Aug, 2020

Anticipated

Primary completion date

Aug, 2019

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 35 - 70

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Veterans with Gulf War Illness
  • 35 to 70 years old
  • Good health by medical history prior to 1990
  • Currently have no exclusionary diagnoses that could reasonably explain the symptoms of their fatiguing illness and their severity

Exclusion Criteria:

  • Major depression with psychotic or melancholic features
  • Schizophrenia
  • Bipolar disorder
  • Delusional disorders
  • Dementias of any type
  • History or current alcohol abuse
  • History or current drug abuse
  • Current tobacco use
  • Organ failure
  • Defined rheumatologic
  • Inflammatory disorders
  • HIV
  • Hepatitis B and C
  • Primary sleep disorders
  • Steroids
  • Immunosuppressives

Study Design

Enrollment

75 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Curcumin

12 weeks 400mg orally twice a day

experimental: Liposomal Glutathione

12 weeks 630mg orally twice a day

experimental: Placebo Liquid or Capsules

Placebo liquid for Glutathione 120 ml per/ bottle 420 mg/5 ml

Placebo capsules for Curcumin 60 capsules per bottle 400 mg /cap

Interventions

Curcumin

Perform a randomized phase I/II study comparing curcumin (increased bioavailable form, body cell mass-85, 400 mg twice a day) to glutathione (liposomal bioavailable form 630 mg bid), with a 3 month intervention and assessment of safety, efficacy and biomarker response to therapy.

Glutathione

Perform dynamic modeling studies before and after 3 months of therapy, repeating the method used previously in order to compare the response to exercise across groups and better quantify the degree of recovery in treated subjects using an exercise challenge and 9 point in time blood and saliva collections over 24 hours with genomic, cytokine, neuropeptide and cell population studies.

Placebo

Placebo liquid 120 ml per/ bottle

Placebo capsules 60 capsules per bottle 400 mg /cap

With the addition of a Partner PI, redox/methylation expert Dr. Richard Deth, perform studies of antioxidant and methylation-related metabolic status prior to, during and after acute exercise in GWI subjects before and after interventions.

Primary outcome measure

  • Biomarker response to therapy using a VO2 exercise test [ Time Frame: 12 weeks ]
  • Biomarker response to therapy using cytokine panel [ Time Frame: 12 weeks ]

Central Contacts and Locations

Central contacts

Fanny V Collado, RN

305-575-7000fanny.collado@va.gov

Elizabeth Balbin

305-275-5450ebalbin@med.miami.edu

Locations

Miami VA Center

Recruiting

Miami, Florida, United States, 33125

Contacts

Nancy Klimas, MD

305-575-7000Nacy.klimas@va.gov

Fanny Collado, RN

305-575-7000fanny.collado@va.gov

More Information

Sponsor

South Florida Veterans Affairs Foundation for Research and Education

Last update posted

Jan 29, 2020

Last verified

Jan, 2020

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by South Florida Veterans Affairs Foundation for Research and Education on 2020-01-29.